Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
Recruiting
Phase 2
Phase 3
Interventional Study
Burn Scar
Burn Wound
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 65
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 70 (estimated)
- Sponsor
- Birch BioMed Inc · Industry
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About This Trial
The goal of this study is to see how an ingredient called kynurenic acid (which we named "FS2") affects scar formation in people with burn injuries that need skin graft surgery. A cream with FS2 will be used on both the area where the skin graft was placed and the area where the skin was taken (donor site). The cream will be applied after the skin has healed. This study will help us understand if …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Medically able and willing to consent/assent to study requirements
2. Male and female burn patients
3. 12 to 65 years of age (inclusive)
4. Able to understand the study requirements and consent without a translator. Where applicable, participant's legally authorized represent…
Contacts